Build a complete risk management file FDA and MDR auditors expect. Ten documents covering ISO 14971:2019 from plan to post-market surveillance loop.
Instant download. For QA/RA at Class II and III device companies.
Under the old 21 CFR Part 820, risk management was primarily a design controls activity. Under QMSR (effective February 2, 2026), risk management applies across the full product lifecycle: design, production processes, supplier controls, and post-market surveillance.
Most manufacturers' risk management files were built for the old scope. FDA investigators and MDR notified bodies are now looking for the expanded file — and the missing sections are exactly what this toolkit addresses.
Structured in the order you'd build the risk management file.
ISO 14971:2019 §4 compliant RMP covering scope, criteria for risk acceptability, and verification activities. Pre-mapped to FDA QMSR 21 CFR 820.30 and EU MDR Annex I §3. Includes section instructions and auditor guidance.
Systematic hazard identification worksheet per ISO 14971:2019 §5-6. Covers use-related hazards (IEC 62366), energy hazards, biological hazards, sterility, information hazards. Pre-populated with common device hazard categories.
Decision framework for ISO 14971:2019 §7-8. Walks through risk acceptability judgments, control option selection hierarchy (inherent safety → protective measures → information for safety), and benefit-risk determination per §8.7.
ISO 14971:2019 §10 affirmation document template. Required section structure: implementation verification, residual risk evaluation, overall residual risk judgment, PMSR plan reference. Audit-ready format.
Closes the ISO 14971 loop with PMS data. Maps PMSR requirements (§10), FDA QMSR 820.200, and EU MDR Article 83/Annex III. Includes KPI table, trigger thresholds for risk file updates, and feedback loop documentation.
Side-by-side ISO 14971:2019 requirements vs. FDA QMSR vs. EU MDR Annex I — 80+ checkpoints. Identifies dual-compliance gaps. Use as pre-audit readiness check for combined FDA/MDR audits.
Three complete device-specific risk analyses per ISO 14971:2019: Class II surgical instrument, powered diagnostic device, implantable device. Shows actual hazards, causes, severity/probability scoring, controls, and residual risk justification.
Define and defend your risk scales per ISO 14971:2019 §4.4(b) and ISO TR 24971. Includes S1-S5 severity definitions with device-type examples, P1-P5 probability calibration, and guidance on how to justify your matrix to auditors.
Benefit-risk determination template per ISO 14971:2019 §8.7 and §9. Structured to produce the affirmation statement auditors require. Includes benefit characterization, residual risk categories, and the FDA benefit-risk framework alignment.
Links every risk control measure to its verification evidence. Traceability matrix format: hazard → control → verification method → evidence reference → sign-off. Required for complete §8.7 documentation and audit traceability.
Under QMSR, risk management now applies to production, suppliers, and post-market — not just design. This toolkit builds the file structure that covers the full lifecycle.
ISO 14971:2019 is the standard both FDA and EU MDR reference. Built for manufacturers under both — not one or the other.
The plan template, hazard worksheets, and report template are fill-in-the-blank. The hardest part of ISO 14971 compliance is building the first version.
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“I built these templates from 12 years of running a Class II/III medical device manufacturing operation. Every document reflects what FDA investigators actually ask for — not what consultants think they ask for. We use these exact frameworks at AB Medical.”
Joshua Millage, CEO — AB Medical Technologies
“When you've been through enough FDA inspections, you learn what documentation gaps get flagged and which ones slide. These templates close the gaps that matter. We developed them alongside our own QMS buildout and they've held up under audit.”
Rick, Director of Engineering & Regulatory — AB Medical Technologies
ISO 14971:2019. All templates and guidance reflect the current standard — including the shift from ALARP to criteria-based risk acceptability, the expanded post-production requirements, and the benefit-risk analysis framework FDA and MDR now require.
Yes. The audit alignment checklist (Document 06) maps every ISO 14971 requirement to both FDA QMSR expectations and EU MDR/notified body expectations side-by-side. The other documents include jurisdiction-specific annotations throughout.
Probably yes, if your procedure was built on ISO 14971:2007 or doesn't cover production and post-market processes (the QMSR expansion). The audit checklist will show you the gaps in about 30 minutes.
No. This is a practitioner reference toolkit. Consult your regulatory counsel for formal compliance opinions.
Start with the right structure. Add your device-specific data. Satisfy both FDA and MDR.
Also: QMSR Toolkit $297 · Full Bundle $449